Like anyone else, coming to the end of the year brings a time of reflection and anticipation. I look back and ask the question, "Have I made a difference in anyone's life?" I look forward and ask, "What do I want to change that I either have control or can influence?"
For the pharmaceutical professional, these questions are not only personal--but professional.
The Quality Assurance professional should always have the sense of a high calling. That calling needs to go beyond being the "checker" who culls out the defects to being the applied scientist or engineer who helps to design quality into the product.
This reminds me of the dear soul who proudly showed me the bucket of discarded product that she plucked off the conveyor belt. The occasion was a plant tour to understand how this company saw the role of the quality function. The next stop on the tour was the QC lab that was backed-up with samples. The analysts were randomly selecting their favorite tests to squeeze in before their next coffee break. It didn't take long to determine that the view of the quality function at this client was anchored in---approximately the 1950s.
On the other hand, there are companies on the cutting edge science and technology with breakthrough products that fulfill the dire need of desperately sick people. Yet, in their evolution, these very bright people did not pay sufficient attention to FDA compliance.
Looking back...
As I look back, I see pharma companies ranging in their quality assurance evolution from knuckles still dragging the ground to walking upright, but tripping over their own feet. So there is still plenty of work to do, and the enlightened--and bold--quality professional is not short of ground material to make a difference.
I say "bold" for a reason. In my opinion, the single factor holding back the quality professional, and consequently the company is the lack of courage.
The economy is not to blame for everything, but working on the inside of just about any company is an environment that is fraught with fear. Timidity is rampant. It is rare to find someone who has the balance of panache and guts to tell the Emperor that he is butt naked. It is a game of not making waves, keeping your head low--and for Pete's sake never pointing out a problem to your manager that makes him have to speak to his director. (Like that's going to happen.)
Looking forward...
My prediction is that the winnowing process will continue in our industry and those with neutered quality assurance departments will either be acquired and rehabbed--or fail. In true Darwinian fashion, the fittest will survive to reproduce.
Regardless of the situation, I would suggest these resolutions for the quality assurance professional:
1. I will make myself more valuable through continuing education that will make me a more enlightened quality professional. These will include real courses from recognized institutions, not trendy certifications.
2. I will find my voice and speak up when I see unacceptable quality and regulatory compliance risks. I may need personal coaching on how to deliver negative messages, but I will not stop going up the chain of command until I am satisfied that reasonable action has been taken.
3. I will learn how to make the business case when I see an opportunity for improvement. As a professional who has been conditioned not to be influenced by cost, I need to learn to how to develop and deliver proposals that speak in the universal language of business---money.
4. I will get out of my cubicle to see what others are doing to broaden my industry perspective. I will resist the notion that my daily working experience is necessarily typical of the industry.
5. I will understand how my role fits into the business process cycle and will hold myself accountable for results, even if the results are bad news. This may mean developing standard cycle times and finding efficiencies to complete my part on time.
6. (And my personal favorite) I will no longer prepare a useless slide deck for a management presentation on "what went wrong and recommendations" until management has supported the recommendations from the previous presentation for the same problems that went wrong. I give myself permission to expect more out of management, especially when it comes to doing my job right.
Happy New Year!
The QA Pharm
